Prostate Cancer Clinical Trial
Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Summary
This phase II trial is studying how well eribulin mesylate (E7389; Halichondrin B Analog) works in treating patients with metastatic prostate cancer that did not respond to hormone therapy. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Full Description
PRIMARY OBJECTIVES:
I. Determine the number of patients with a > 50% decrease in prostate-specific antigen (PSA) of at least 4 weeks duration in patients with hormone-refractory metastatic prostate cancer treated with E7389 (eribulin mesylate).
SECONDARY OBJECTIVES:
I. Estimate the measurable disease response in patients with measurable disease.
II. Determine the duration of PSA and measurable disease response.
III. Characterize the safety and tolerability of E7389 in these patients.
OUTLINE:
This study enrolled 3 cohorts of patients based on the number of prior chemotherapy regimens received. The 3 cohorts are chemonaive stratum, prior-taxane stratum, and two-prior-chemotherapy stratum. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the prostate
Progressive metastatic disease or stable metastatic disease with rising PSA
Previously treated with bilateral orchiectomy or other primary hormonal therapy with evidence of treatment failure
Patients who have not undergone bilateral orchiectomy must continue luteinizing hormone-releasing hormone (LHRH)-agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist therapy (e.g. abarelix) while receiving study treatment
Patients who did not have an orchiectomy must have a testosterone level < 50 ng/dL to confirm androgen suppression within the past 4 weeks
ECOG performance status 0-2
Adequate bone marrow function
Bilirubin =< 1.5 mg/dL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal
Creatinine =< 2.0 mg/dL OR creatinine clearance >= 40 mL/min
Fertile patients must use effective contraception
A taxane-based regimen, mitoxantrone, or other cytotoxic chemotherapy regimen allowed provided there is evidence of disease progression
At least 4 weeks since prior chemotherapy or radiotherapy
At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and there is continued evidence of disease progression
Disease progression after antiandrogen withdrawal must be confirmed by rising PSA after the required 4-6 week washout period (e.g., PSA level higher than the last PSA obtained while on antiandrogen therapy)
More than 4 weeks since prior estrogen, estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products that may contain phytoestrogens), or any other hormonal therapy (including megestrol, finasteride, ketoconazole, or systemic corticosteroids)
Concurrent bisphosphonates (e.g., pamidronate sodium or zoledronate) allowed provided the patient has been receiving the bisphosphonate for >= 4 weeks and there is evidence of disease progression
Exclusion Criteria:
Active angina pectoris
Known New York Heart Association class III-IV heart disease
Myocardial infarction within the past 6 months
Evidence of ventricular dysrhythmias or other unstable arrhythmia (rate-controlled atrial fibrillation is allowed if the patient is asymptomatic from a cardiac standpoint)
Peripheral neuropathy > grade 2
Other prior malignancy (excluding nonmelanomatous skin cancer treated with curative intent) unless the malignancy was treated with curative intent and the patient has been disease free for >= 5 years
Serious concurrent medical illness or active infection that would preclude study treatment - No concurrent strong inhibitors or inducers of CYP3A4
More than 2 prior chemotherapy regimens for hormone-refractory disease - Other concurrent investigational agents
Other concurrent anticancer therapy, including chemotherapy, gene therapy, biologic therapy, or immunotherapy
Concurrent palliative radiotherapy
Concurrent estrogen, estrogen-like agents, or any other hormonal therapy
Carcinomatous meningitis or brain metastases
Prior strontium chloride Sr 89, samarium 153 lexidronam pentasodium, or other radioisotopes
Concurrent therapeutic anticoagulation with warfarin (Unfractionated heparin [standard, low-dose, or adjusted dose] or low molecular weight heparin allowed
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 118 Locations for this study
Scottsdale Arizona, 85259, United States
Monterey California, 93940, United States
Manchester Connecticut, 06040, United States
Boca Raton Florida, 33486, United States
Jacksonville Florida, 32224, United States
Aurora Illinois, 60504, United States
Bloomington Illinois, 61701, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Chicago Illinois, 60616, United States
Decatur Illinois, 62526, United States
Elgin Illinois, 60123, United States
Eureka Illinois, 61530, United States
Evanston Illinois, 60201, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Hopedale Illinois, 61747, United States
Joliet Illinois, 60435, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Moline Illinois, 61265, United States
Moline Illinois, 61265, United States
Moline Illinois, 61265, United States
Moline Illinois, 61265, United States
Moline Illinois, 61265, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61603, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Skokie Illinois, 60076, United States
Spring Valley Illinois, 61362, United States
Springfield Illinois, 62781, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Elkhart Indiana, 46515, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Michigan City Indiana, 46360, United States
Mishawaka Indiana, 46545, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
Ames Iowa, 50010, United States
Bettendorf Iowa, 52722, United States
Cedar Rapids Iowa, 52403, United States
Cedar Rapids Iowa, 52403, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 50307, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51104, United States
Sioux City Iowa, 51104, United States
Boston Massachusetts, 02215, United States
Adrian Michigan, 49221, United States
Adrian Michigan, 49221, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Dearborn Michigan, 48124, United States
Detroit Michigan, 48236, United States
Escanaba Michigan, 49431, United States
Flint Michigan, 48502, United States
Flint Michigan, 48532, United States
Iron Mountain Michigan, 49801, United States
Jackson Michigan, 49201, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Monroe Michigan, 48162, United States
Monroe Michigan, 48162, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Saginaw Michigan, 48601, United States
St. Joseph Michigan, 49085, United States
Warren Michigan, 48093, United States
Bemidji Minnesota, 56601, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Hutchinson Minnesota, 55350, United States
Litchfield Minnesota, 55355, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Rochester Minnesota, 55905, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Woodbury Minnesota, 55125, United States
Flemington New Jersey, 08822, United States
Hackensack New Jersey, 07601, United States
Hamilton New Jersey, 08690, United States
Mount Holly New Jersey, 08060, United States
New Brunswick New Jersey, 08903, United States
Voorhees New Jersey, 08043, United States
Bronx New York, 10466, United States
New York New York, 10016, United States
Fargo North Dakota, 58122, United States
Fargo North Dakota, 58122, United States
Bowling Green Ohio, 43402, United States
Cleveland Ohio, 44106, United States
Clyde Ohio, 43410, United States
Elyria Ohio, 44035, United States
Lima Ohio, 45804, United States
Maumee Ohio, 43537, United States
Maumee Ohio, 43537, United States
Maumee Ohio, 43537, United States
Oregon Ohio, 43616, United States
Oregon Ohio, 43616, United States
Sandusky Ohio, 44870, United States
Sylvania Ohio, 43560, United States
Tiffin Ohio, 44883, United States
Toledo Ohio, 43606, United States
Toledo Ohio, 43608, United States
Toledo Ohio, 43614, United States
Toledo Ohio, 43617, United States
Toledo Ohio, 43623, United States
Toledo Ohio, 43623, United States
Wauseon Ohio, 43567, United States
Abington Pennsylvania, 19001, United States
Bethlehem Pennsylvania, 18015, United States
Hershey Pennsylvania, 17033, United States
Lewistown Pennsylvania, 17044, United States
State College Pennsylvania, 16803, United States
Fredericksburg Virginia, 22401, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Madison Wisconsin, 53715, United States
Madison Wisconsin, 53792, United States
Marinette Wisconsin, 54143, United States
Oconto Falls Wisconsin, 54154, United States
Sturgeon Bay Wisconsin, 54235, United States
Wisconsin Rapids Wisconsin, 54494, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.